Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device
In this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system.
Archive for category: Risk Management Page 3
What is Medical Device Risk Management?
May 14, 2020 in Risk Management Medical Device & Life Sciences /by Jama SoftwareBuilding and then bringing a medical device to market as quickly as possible—all while preserving acceptable levels of quality and regulatory compliance—requires adept medical device risk management. By minimizing potential risks such as mislabeling and software-related issues, medical device manufacturers make each product safer for the patients who will use them. All of these risks […]
An Interview with Award-Winning Medical Device Risk Management Educator and Author Bijan Elahi
February 13, 2020 in Risk Management Medical Device & Life Sciences /by Bijan ElahiWe sat down with award-winning medical device risk management educator, author, and consultant Bijan Elahi to hear his thoughts on risk management in medical device development.
Answers to Your Questions About Risk Management and FMEA
July 23, 2019 in Risk Management Aerospace & Defense, Automotive, Financial Services & Insurance, Medical Device & Life Sciences /by Jama SoftwareYou’ll gain more confidence that your recently-released products avoid recalls, fines, or worse if you perform failure mode and effects analysis (FMEA) as part of your risk management.
Avoid Product Recall and Failure with Better Requirements and Risk Management
May 28, 2019 in Risk Management Aerospace & Defense, Automotive /by McKenzie JonssonDeveloping complex systems and products requires teams to have the ability to effectively define and track requirements, adhere to safety-critical regulations, collaborate and communicate effectively across teams and functions, and evaluate and mitigate potential risks.
Frost & Sullivan: Jama Connect Improves Risk Management Amid Growing Product Complexity
May 14, 2019 in Risk Management Aerospace & Defense, Automotive, Medical Device & Life Sciences, Semiconductor /by Jama SoftwareProminent research and consulting firm Frost & Sullivan recently observed the product development landscape and its relationship to risk. The output is a recently-released brief, “Safeguarding Regulated Products Amidst Growing Complexity,” that spotlights Jama Connect™ as a remedy for ineffective risk analysis in product development.
Why The Greatest Threat To The United States Is Our Own Self-Defense
January 9, 2018 in Risk Management /by Neil BjorklundDuring a December panel at the Reagan National Defense Forum in Simi Valley, California, moderator Trish Regan of Fox News asks, “Who do you consider to be the biggest threat in terms of having the most cutting-edge technology for their military right now?”
Simple question, right?
Knowing Your Enemy: An Introduction to Risk Management
March 26, 2014 in Risk Management /by Karl WiegersSoftware engineers are eternal optimists. When planning software projects, we usually assume that everything will go exactly as planned. Or, we take the other extreme position: the creative nature of software development means we can never predict what’s going to happen, so what’s the point of making detailed plans? Both of these perspectives can lead […]
Know Your Enemy: An Introduction to Risk Management, Part 2
September 20, 2013 in Risk Management /by Karl WiegersIn the first part of this two-part series I described the value of managing risks formally on a software project and listed numerous common risks in various categories. This article describes the various activities associated with the practice of risk management and recommends specific information you should record about each risk you identify. Risk Management […]
Know Your Enemy: An Introduction to Risk Management, Part 1
September 16, 2013 in Risk Management /by Karl WiegersSoftware engineers are eternal optimists. When planning software projects, we usually assume that everything will go exactly as planned. Or, we take the other extreme position: the creative nature of software development means we can never predict what’s going to happen, so what’s the point of making detailed plans? Both of these perspectives can lead […]